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Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome

Expanded access is currently available for this treatment.
Verified October 2008 by University of Texas Southwestern Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00765557
First Posted: October 3, 2008
Last Update Posted: October 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by:
University of Texas Southwestern Medical Center
September 30, 2008
October 3, 2008
October 3, 2008
 
Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome

We hypothesize fecal retention is the primary source of bladder dysfunction in some children with Urge Syndrome. Our specific aims are:

  1. To test this hypothesis through a prospective, randomized, double-blinded and placebo-controlled trial of laxatives for children diagnosed with US.
  2. To determine if a validated questionnaire of bowel activity administered to the family, and when appropriate, the patient, will identify those likely to benefit from laxative therapy for bladder dysfunction.
  3. To determine if the abdominal X-Ray of the kidneys, ureters and bladder (KUB) assessment of fecal loading corresponds to answers on the questionnaire regarding incidence of constipation, and/or response to laxative therapy for US.
Not Provided
Expanded Access
Drug: Miralax
Every subject will be given one bottle of the laxative/placebo, and depending on the patient's weight, will be instructed to take 1-3 tsps (.75 gm/kg) of the medication daily.
Not Provided
 
Available
Contact: Warren T Snodgrass, M.D. 214-456-2483 Warren.Snodgrass@childrens.com
Not Provided
 
 
NCT00765557
Warren T. Snodgrass, M.D., University of Texas Southwestern Medical School
University of Texas Southwestern Medical Center
Not Provided
Not Provided
University of Texas Southwestern Medical Center
October 2008